Standards Development

Scope

This document specifies requirements and test methods for the design and performance of packaging systems used for transporti ng medical devices provided non-sterile to the point of use. Product designed and developed to be shipped non -sterile from the manufacturer is covered by the requirements in this document. It does not apply to product sterilized within sterile barrier sy stems which are covered by ISO 11607-1/-2.

It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation o f the item to the site of reprocessing or disposal.

Purpose

In accordance with ISO/TC 122 strategic business plan, this proposed standard will provide cost effective and more reliable requirements allowing for clear, unambiguous technical specifications through harmonization and clarification. Regulatory aut horities recognize the critical nature of packaging systems by considering them as an accessory or a component of a medical device. Me dical device manufacturers have seen the value of ISO 11607-1 “Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems” and have utilized this standard to demonstrate compliance to re gulatory authorities and notified bodies. Until this time, a corresponding standard for non -sterile medical device packaging has not existed. Emulating the agreed upon framework of ISO 11607, this proposed standard will aid medical device manufacturers by providing a standard which may be used to support submissions to regulatory bodies including but not limited to: US Food & Drug Administration, Therapeutic Goods Administration of Australia, Brazil's Agência Nacional de Vigilância Sanitária, Health Canada, the Japanese Pharmaceuticals and Medical Devices Agency and the European Union General Safety and Performance Requirement s under the MDR 2017/74.